Jim Miller, President, PharmSource Information Services, Inc., sounds as much like a travel agent as a pharma outsourcing prognosticator at his DCAT Week ’17 market overview on pharmaceutical contract development and manufacturing: Pharma’s billions for biologics are staying home; small molecules continue to hit the road.
Integrating a contract service provider (CSP) as part of a supply chain to bring a product to market is a critical decision that impacts business performance and carries regulatory and compliance risk. The selection considerations can vary substantially as your program moves from early development contract research to commercial manufacturing and analytical support.
Developing and launching a pharmaceutical product is a highly risky venture. Recent studies show that the overall success rate from Phase 1 to FDA approval is now less than 10 percent (Seaton, 2014), and many of those do not achieve commercial success. At the same time, the pharmaceutical industry is moving toward an outsourced manufacturing model using CDMOs (contract development and manufacturing organizations), which further compounds the risks by adding knowledge transfers, competing priorities, and lack of control. Building strong and mutually beneficial outsourcing partnerships is crucial to achieving success for small, midsize, and even Big Pharma companies.
This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
By upgrading from ÄKTAexplorer to ÄKTA avant chromatography system, you can improve productivity in process development. Depending on your application and how the system is operated, different ways to improve your productivity will have varying impact. Here we show 10 ways to boost your productivity.
With things “heating up” in terms of more diverse temperature demands, the industry is moving away from the term cold chain, and we’ll start to see more references to the more inclusive temperature-controlled transport.
Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base.
Development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments.
Patheon’s Puerto Rico Operations specialize in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.
Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.
Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.
Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.
With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.
Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.
The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed.
In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.